KR20210015190A - Glucose monitoring device based on electrocardiogram measurement - Google Patents

Abstract

The present invention relates to a technology which is closely placed on the skin of a user to acquire a blood glucose measurement and an electrocardiogram measurement, provides the blood glucose measurement which is verified as an effective blood glucose measurement based on the electrocardiogram measurement, and thus reliably monitors the blood glucose measurement. A blood glucose monitoring device based on an electrocardiogram measurement according to the present invention comprises: a sensor module which comprises an electrocardiogram sensor for measuring an electrocardiogram of a user and a blood glucose sensor for measuring blood glucose of the user while being closely placed on the skin of the user; a measurement device which comprises a control part for collecting an electrocardiogram measurement by a first cycle and collecting a blood glucose measurement by a second cycle which is set to be longer than the first cycle from the sensor module, generating blood glucose monitoring information including the blood glucose measurement measured by the second cycle, and transmitting the blood glucose monitoring information to a monitoring terminal when the electrocardiogram measurement does not deviate from a preset normative range of electrocardiogram; and the monitoring terminal which receives the blood glucose monitoring information from the measurement device and displays and outputs the same. The sensor module comprises: on one side of a body having a predetermined size, an electrocardiogram measurement sensor in which a ground electrode and an electrocardiogram measurement electrode are vertically arranged at a predetermined distance apart while facing each other; on the other side of the body having the electrocardiogram measurement sensor arranged, a blood glucose sensor comprising a microneedle with a length penetrating into a skin dermal layer region of the user. A coating layer that changes electrical properties to correspond to a glucose amount contained in blood is formed on the external surface of the microneedle.

Description

Blood glucose monitoring device based on electrocardiogram measurement

The present invention is arranged in close contact with the user's skin to obtain a blood glucose measurement value and an electrocardiogram measurement value, and provides the user with a blood glucose measurement value determined as an effective blood glucose measurement value based on the electrocardiogram measurement value, thereby more reliable blood glucose measurement value. It relates to a technology that allows you to monitor the data.

Diabetes, one of the lifestyle-related diseases of modern people, currently accounts for about 5% of the total population, and its number is gradually increasing. Diabetes is a major problem in the modern society, with it is expected to increase from 83% of the total population in 2013, or 382 million, to 101%, or 592 million, in 2035.

Diabetes is a chronic disease that cannot be cured once it occurs, and it is a type of disease that requires self-management throughout life. It is a well-known fact that thorough glucose control in our body is the most basic of diabetes management, including prevention of complications. Check the party status through.

Blood glucose level is a value representing the amount of glucose in the blood, and is known to be in the range of 4 mmol/Liter or 72 mg/dL in our body, but this value changes according to human metabolism during the day. That is, the general human blood sugar concentration is in the range of 70 to 130 mg/dL before meals and 180 mg/dL after meals. Cases exceeding this range are classified as hyperglycemia, and cases below the normal range are classified as hypoglycemia. In general, hyperglycemia may correspond to a condition in which diabetes has already existed, progression to diabetes, or diabetes has not yet been discovered, and thus hyperglycemia has a significant association with diabetes.

The most common way to measure blood glucose level is blood collection. In the blood sampling method, blood is obtained by stabbing the tip of a finger with a sterile needle, etc., and the blood glucose level in the blood is measured by analyzing it.

However, even in the case of normal people who are not diabetic patients, the mental burden of blood glucose measurement by the blood sampling method is high because of fear of collecting blood by wounding the fingertips. Accordingly, users are demanding a method of measuring blood sugar in a bloodless manner.

In addition, in the case of diabetic patients, it is necessary to periodically measure the blood sugar value in order to maintain and control the blood sugar at an appropriate level. In particular, patients with type 1 diabetes have a greater need to continuously measure blood sugar levels.

However, the blood collection method is a one-time method and cannot be applied to patients who require continuous blood glucose monitoring. In addition, diabetic patients have a problem in that the blood glucose level cannot be measured by using the blood sampling method more than four times a day because the wound recovery is slow and there is a concern of complications when the body is damaged.

Accordingly, in recent years, a continuous glucose monitoring system (CGMS) that continuously measures blood glucose values and provides information on blood glucose trends has been developed.

As one of the continuous blood sugar detection systems, there is a patch-type blood sugar measurement device that is attached to the human body and used. As long as the blood glucose measurement device is attached to the user's body, the blood glucose value can be continuously measured, so there is an advantage in that the blood glucose can be continuously measured.

Prior Document 1 discloses a configuration of a blood glucose measurement sensor including a needle inserted into a user's skin as a sensor capable of continuously monitoring blood glucose levels in the body as a device for measuring blood sugar.

However, since such a patch-type continuous blood glucose measurement device is measured for a certain amount of time or longer, it guarantees a certain amount of activity to the user, so that the blood glucose measurement value differs from the actual blood glucose value in the body due to the influence of wind during outdoor activities. Can be measured.

1. Domestic Patent No. 10-1512566 (Name: Continuous Blood Sugar Monitoring Sensor)

Accordingly, the present invention was created in consideration of the above circumstances, and is disposed in close contact with the user's skin to obtain a blood glucose measurement value and an electrocardiogram measurement value, and a blood glucose measurement value determined as an effective blood glucose measurement value based on the electrocardiogram measurement value. The present invention relates to a blood glucose monitoring device based on an electrocardiogram measurement value that provides a user with a more reliable monitoring of the blood glucose measurement value.

According to an aspect of the present invention for achieving the above object, a sensor module including an electrocardiogram sensor for measuring a user's electrocardiogram and a blood sugar sensor for measuring a user's blood sugar in a state in close contact with the user's skin, and When the ECG measurement value is collected in units of one cycle and the blood glucose measurement value is collected in units of a second cycle that is set longer than the first cycle, and the measured value of the ECG does not deviate from the preset ECG reference range, it is measured at the second cycle. A measurement device comprising a control unit that generates blood glucose monitoring information including the measured blood glucose value and transmits it to a monitoring terminal, and a monitoring terminal that receives and displays blood glucose monitoring information from the measurement device. The sensor module is provided with an electrocardiogram measuring sensor arranged up and down at a certain distance apart while the ground electrode and the electrocardiogram measuring electrode face each other on one side of the body having a certain size, and the skin dermal layer of the user is located on the other side of the body where the electrocardiogram measuring sensor is disposed An electrocardiogram measurement value, characterized in that a blood glucose sensor including a microneedle having a length penetrating to the area is provided, and a coating layer that changes electrical properties in response to the amount of glucose contained in the blood is formed on the outer surface of the microneedle. An apparatus for measuring blood sugar based is provided.

In addition, the control unit determines whether the currently collected blood glucose measurement value deviates from the preset reference blood glucose range when the electrocardiogram measurement value collected in the first cycle unit before collecting the current blood glucose measurement value does not deviate from a preset electrocardiogram reference range, and , If the currently collected blood glucose measurement value deviates from a preset reference blood glucose range, there is provided a blood glucose measurement device based on an electrocardiogram measurement value, characterized in that the notification information is generated and transmitted to the monitoring terminal, indicating that the current blood glucose measurement value is invalid Is provided.

In addition, the control unit collects the blood glucose measurement value by performing blood glucose measurement regardless of the second cycle when the electrocardiogram measurement value collected in units of the first cycle at the time before collecting the blood glucose measurement value deviates from a preset electrocardiogram reference range, When the currently collected blood glucose measurement value deviates from the blood glucose reference range, blood glucose measurement based on the electrocardiogram measurement value, characterized in that it is configured to generate blood glucose warning information including the current blood glucose measurement value and blood glucose warning information, and transmit it to the monitoring terminal. A device is provided.

In addition, there is provided a blood glucose measurement device based on an electrocardiogram measurement value, wherein the electrocardiogram sensor and the measurement sensor are disposed in a diagonal direction in the body.

In addition, the control unit supplies power to the ground electrode and the electrocardiogram measurement electrode in a first cycle unit to obtain an electrocardiogram measurement value based on the voltage difference output from the ground electrode and the electrocardiogram measurement electrode, and obtains a second unit with a microneedle. There is provided a blood glucose measurement device based on an electrocardiogram measurement value, characterized in that it is configured to obtain a blood glucose measurement value based on a change in current amount by a coating layer of a microneedle by supplying power to the furnace.

According to the present invention, it is possible to more reliably monitor the blood sugar state of the subject to be measured by determining the validity of the currently measured blood glucose measurement value based on the measured value of the electrocardiogram of the subject to be measured, and providing to monitor the effective glucose measurement value. have.

In addition, when an abnormality occurs in the measured value of the electrocardiogram of the subject to be measured, the blood sugar is measured in real time regardless of a preset blood sugar measurement period, so that it is possible to immediately monitor the blood sugar state in the blood sugar abnormal environment.

1 is a diagram showing a schematic configuration of a blood glucose monitoring apparatus based on an electrocardiogram measurement value according to a first embodiment of the present invention.
Fig. 2 is a diagram for explaining the shape of the measuring device 100 shown in Fig. 1;
FIG. 3 is a block diagram showing the internal configuration of the measurement device 100 shown in FIG.
4 is a view for explaining the structure of the sensor module 110 shown in FIG.
5 is a view for explaining the operation of the blood glucose monitoring device based on the ECG measurement value shown in FIG.

Since the embodiments described in the present invention and the configurations shown in the drawings are only preferred embodiments of the present invention, and do not represent all the technical spirit of the present invention, the scope of the present invention is limited to the embodiments and drawings described in the text. Should not be construed as limited by That is, since the embodiments can be variously changed and have various forms, the scope of the present invention should be understood to include equivalents capable of realizing the technical idea. In addition, since the object or effect presented in the present invention does not mean that a specific embodiment should include all of them or only those effects, the scope of the present invention should not be understood as being limited thereto.

All terms used herein have the same meaning as commonly understood by one of ordinary skill in the field to which the present invention belongs, unless otherwise defined. Terms defined in commonly used dictionaries should be interpreted as having meanings in the context of related technologies, and cannot be interpreted as having ideal or excessively formal meanings that are not clearly defined in the present invention.

1 is a diagram showing a schematic configuration of a blood glucose monitoring apparatus based on an electrocardiogram measurement value according to a first embodiment of the present invention.

Referring to FIG. 1, a blood glucose monitoring apparatus based on an electrocardiogram measurement value according to a first embodiment of the present invention includes a measurement device 100 and a monitoring terminal 200.

The measurement device 100 measures the user's electrocardiogram value and blood glucose value in a state in close contact with the user's skin, generates monitoring information including an effective blood glucose measurement value based on the electrocardiogram measurement value, and transmits it to the monitoring terminal 200 do. In this case, the measurement device 100 and the monitoring terminal 200 may perform wired or wireless communication, and are preferably configured to perform wireless communication for a user's degree of freedom of activity.

The monitoring terminal 200 is a terminal that displays and outputs blood glucose information received from the measurement device 100, and the monitoring terminal 200 includes a desktop computer, a laptop computer, a smart phone, a personal digital assistant (PDA), a portable multimedia device (PMP). Player), a navigation terminal, a tablet PC, and the like, which can be connected to a network and have various types of communication devices including a screen for displaying and outputting information.

In this case, the monitoring terminal 200 may be installed with an application for providing a blood sugar monitoring service, and provides a blood sugar monitoring service by interworking with the measurement device 100 according to the execution of the application.

Meanwhile, the measuring device 100 in FIG. 1 may be configured by being combined with a connection member 1 to be easily in close contact with and fixed to the user's body, for example, the user's forearm, as shown in FIG. 2. For example, the connecting member 1 may be configured in the form of a band having a predetermined length and may be configured with a fastening member 2 of a structure or material detachable at both ends thereof. Of course, these connecting members and fastening members have various structures in which the measuring device 100 can be attached and detached from the user's body.

3 is a block diagram showing the internal configuration of the measurement device 100 by functionally separating it. The measurement device 100 includes a sensor module 110, a communication unit 120, a data memory 130, and a power supply unit 140. ), and a device control unit 150. In addition, the measuring device 100 includes an information input means including a power button for setting on/off the operating state of the measuring device 100 and a display lamp for displaying and outputting the operating state of the measuring device 100 It may further include an information output means.

The sensor module 110 includes an electrocardiogram sensor 111 at one end of the sensor body 101 and a blood glucose sensor 112 at the other end of the sensor body 101, as shown in FIG. 4C. At this time, the electrocardiogram sensor 111 and the blood glucose sensor 112 are disposed diagonally at both ends of the body 101 so that the distance between the sensors on the body 101 is maximized. This is to minimize the mutual influence on the measured values of different sensors.

The electrocardiogram sensor 111 includes a ground electrode 111a disposed to protrude a predetermined length from the lower surface of the sensor body 101 in close contact with the user's body, as shown in FIG. 4(D), and the sensor body 111 Consists of an electrocardiogram measuring electrode 111b protruding at a position opposite to the ground electrode 111b on the upper surface, and the ground electrode 111a and the electrocardiogram measuring electrode 111b are spaced apart from the inner layer of the sensor body 101 by a predetermined interval It is arranged so that it is configured up and down. At this time, the ground electrode 111a and the electrocardiogram measuring electrode 111b are connected to the power supply unit 140 and the device control unit 150, and the ground electrode 111a is connected to the ground.

In addition, the blood sugar sensor 112 has a rod shape having a predetermined length, and includes a microneedle 112b having a tip part 112c and a blood sugar electrode 112b. In this case, the microneedles 112a and the blood sugar electrode 112b may be integrally formed, and of course, the microneedles 112a may be formed to extend a predetermined length.

In addition, the length of the microneedle 112a in the blood glucose sensor 112 is appropriately set so that the tip part 112c is located in the dermal layer of the user's skin, as shown in FIG. 4E. For example, the protruding length of the microneedle 112a may be generally set in the range of about 70 μm to 1300 μm in consideration of the average thickness of the skin for each position of the human body.

That is, the blood sugar sensor 112 is formed in a form in which the microneedle 112a protrudes from the lower surface of the sensor body 101 in close contact with the user's body, and the blood sugar electrode 112b protrudes from the upper surface of the sensor body 101. . In addition, the blood sugar electrode 112b is connected to the power supply unit 140 and the device control unit 150.

Meanwhile, in FIG. 3, the communication unit 120 transmits and receives information related to blood sugar monitoring with the monitoring terminal 200.

The data memory 130 is a reference including an electrocardiogram reference range, a blood glucose reference range, an electrocardiogram measurement period and a blood glucose measurement period, an electrocardiogram measurement value corresponding to the voltage difference of the electrocardiogram sensor, and a blood glucose measurement value corresponding to the current value of the blood glucose sensor. It stores information related to blood glucose monitoring including information. At this time, the ECG measurement cycle is set to be shorter than the blood glucose measurement cycle. For example, the ECG measurement period may be set to 20 seconds per minute, and the blood glucose measurement period may be set to once per 10 minutes.

The power supply unit 140 supplies operating power Vcc to the measurement device 100. In this case, the power supply unit 140 may be composed of a battery.

The device controller 150 collects the ECG measurement value from the ECG sensor 112 in a preset ECG measurement period unit, collects the blood glucose measurement value from the blood glucose sensor 113 in a preset blood glucose measurement period unit, and measures the ECG Based on the value, blood glucose monitoring information including a blood glucose measurement value determined to be valid is generated and controlled to be transmitted to the monitoring terminal 200 through the communication unit 120.

In addition, the device controller 150 determines whether the blood glucose measurement value is valid based on whether the ECG measurement value and the blood glucose measurement value deviate from the reference range, and generates blood glucose value invalid guidance information or blood glucose warning information based on this 120) through the control to be transmitted to the monitoring terminal 200.

At this time, the device control unit 150 controls the supply of power applied to the electrocardiogram sensor 112 and the blood glucose sensor 113 through the power supply unit 140, thereby collecting the corresponding measured values corresponding to the electrocardiogram measurement period and the blood glucose measurement period. can do.

That is, the device control unit 150 supplies a certain level of power for ECG measurement to the ECG sensor 111, and the voltage measured from the ground electrode 111a and the ECG measurement electrode 111b of the ECG sensor 111 Based on the difference, the ECG measurement value is acquired.

In addition, the device control unit 150 supplies a certain level of power to the blood sugar sensor 112 for measuring blood sugar, and for this, calculates a blood sugar measurement value based on the amount of current conducted from the microneedle 112a to the blood sugar electrode 112b. Acquire.

Next, the operation of the blood glucose monitoring apparatus based on the ECG measurement value according to the present invention will be described with reference to the flowchart shown in FIG. 5.

The measuring device 100 is fixed in close contact with the body of the person to be measured to monitor blood sugar. At this time, the microneedles 112a of the measurement device 100 penetrate to the dermal layer of the skin of the subject to be measured.

In addition, the user executes an application for monitoring blood glucose in the monitoring terminal 200 and sets the measurement device 100 to an operating state. The method of setting the measurement device 100 to the operating state is performed through communication setting between the monitoring terminal 200 and the measurement device 100, or a power button (not shown) provided in the measurement device 100 is turned on. It may be made in various ways such as "setting to a state, but is not limited thereto.

As described above, in a state in which the application is running on the monitoring terminal 200 and the measurement device 100 is set to an operating state, the measurement device 100 receives the ECG measurement value through the ECG sensor 112 in a first cycle unit. It is acquired, and a blood glucose measurement value is acquired through the blood glucose sensor 113 in a second cycle unit (ST110). In this case, the first period of acquiring the ECG measurement value is set shorter than the second period of acquiring the blood glucose measurement value.

The measuring device 100 checks an electrocardiogram measurement value acquired in a first cycle unit and determines whether it is out of a preset electrocardiogram reference range (ST120). For example, the measurement device 100 may determine whether the ECG measurement value exceeds the ECG reference range.

In a state in which the current ECG measurement value does not exceed the ECG reference range in step ST120, the measurement device 100 determines whether the current blood glucose measurement value exceeds a preset blood glucose reference range (ST130). The measurement device 100 determines whether the ECG measurement values collected in the first cycle unit from the previous blood glucose measurement value collection to the time before the current blood glucose measurement value collection do not deviate from a preset ECG reference range. For example, the measurement device 100 may determine whether the blood glucose measurement value exceeds the ECG reference range.

When the current blood glucose measurement value does not exceed the blood glucose reference range in step ST130, the measurement device 100 generates monitoring information including the currently acquired blood glucose measurement value and transmits it to the monitoring terminal 200 (ST140). In this case, the monitoring information may be configured to additionally include an electrocardiogram measurement value acquired at a time point closest to the blood glucose measurement value. That is, when the ECG measurement value is normal and the blood glucose measurement value is also normal, the measurement device 100 generates monitoring information in a second periodic unit and transmits it to the monitoring terminal 200.

In addition, when the current blood glucose measurement value is out of the ECG reference range in the step ST130, the measurement device 100 determines that the blood glucose measurement value has been temporarily changed due to noise caused by the movement of the person to be measured or the surrounding environment, and noise generation alarm information. And transmits the noise generation alarm information to the monitoring terminal 200 (ST150). This takes into account a physical situation in which an electrocardiogram increases when blood sugar rises, and the effectiveness of the blood sugar measurement value is determined through this.

On the other hand, when the current ECG measurement value is out of the ECG reference range in the ST120 step, the measurement device 100 determines that the event has a problem with blood sugar and performs blood sugar measurement regardless of a preset blood sugar measurement cycle. Is obtained (ST160). For example, when the ECG increases, the blood glucose measurement period is arbitrarily additionally set so that the current blood glucose state of the subject to be measured can be immediately checked in consideration of the increase in blood glucose.

Subsequently, the measurement device 100 determines whether the blood glucose measurement value obtained in the event situation of step ST160 is out of a preset blood glucose reference range (ST170). Here, the measurement device 100 may determine whether the blood glucose measurement value exceeds the blood glucose reference range.

In addition, the measurement device 100 determines that an abnormality has occurred in the blood sugar of the subject to be measured when the blood sugar measurement value is out of the blood sugar reference range in the ST170 step, and a blood sugar warning including the current blood sugar measurement value and the recently measured ECG measurement value Information is generated and transmitted to the monitoring terminal 200 (ST180). In this case, the blood sugar warning information may additionally include a blood sugar state (high blood sugar/low blood sugar, etc.) corresponding to the current blood sugar deviation range, and may further include emergency treatment guide information corresponding to the blood sugar state.

Thereafter, the measurement device 100 terminates the above-described blood glucose measurement operation by setting the power to the OFF state.

On the other hand, the monitoring terminal 200 accumulates and manages monitoring information (blood sugar monitoring information and blood sugar warning information) received from the measurement device 100 to more reliably determine the change in blood sugar of the measurement target based on an effective blood sugar measurement value. I can.

100: measuring device, 200: monitoring terminal,
110: sensor module, 111: electrocardiogram sensor,
112: blood sugar sensor, 101: sensor body,
120: communication unit, 130: data memory,
140: power supply unit, 150: device control unit.

Claims (5)

In a state in close contact with the user's skin, a sensor module including an electrocardiogram sensor that measures the user's electrocardiogram and a blood glucose sensor that measures the user's blood sugar, and collects the ECG measurement value from the sensor module in units of a first cycle, In addition to collecting blood glucose measurement values in units of a second period that is set for a long time, when the ECG measurement value does not deviate from the preset ECG reference range, blood glucose monitoring information including the blood glucose measurement value measured in the second period is generated and monitored. A measurement device comprising a control unit for transmitting to the terminal,
And a monitoring terminal receiving and displaying blood glucose monitoring information from the measuring device,
The sensor module is provided with an electrocardiogram measuring sensor arranged up and down a predetermined distance apart while the ground electrode and the electrocardiogram measuring electrode face each other on one side of the body having a certain size, and the user's skin is located on the other side of the body on which the electrocardiogram measuring sensor is disposed. Electrocardiogram measurement, characterized in that a blood glucose sensor including a microneedle having a length penetrating to the dermal layer is provided, and a coating layer that changes electrical properties in response to the amount of glucose contained in the blood is formed on the outer surface of the microneedle. Value-based blood glucose measurement device.
The method of claim 1,
The control unit determines whether the currently collected blood glucose measurement value deviates from the preset reference blood glucose range when the electrocardiogram measurement value collected in a first cycle unit before collecting the current blood glucose measurement value does not deviate from a preset electrocardiogram reference range, and When the collected blood glucose measurement value deviates from a preset reference blood glucose range, notification information notifying that the current blood glucose measurement value is invalid is generated and transmitted to a monitoring terminal.
The method according to claim 1 or 2,
The control unit collects the blood glucose measurement value by performing blood glucose measurement regardless of the second cycle when the ECG measurement value collected in the first cycle unit at the time before the blood glucose measurement value is collected deviates from the preset ECG reference range. When the measured blood glucose value deviates from the blood glucose reference range, blood glucose warning information including a current blood glucose measurement value and a blood glucose warning guide is generated and transmitted to a monitoring terminal.
The method of claim 1,
The electrocardiogram sensor and the measurement sensor are arranged in a diagonal direction from the body.
The method of claim 1,
The control unit supplies power to the ground electrode and the electrocardiogram measurement electrode in a first cycle unit to obtain an electrocardiogram measurement value based on the voltage difference output from the ground electrode and the electrocardiogram measurement electrode, and powers the second unit with a microneedle. A blood glucose measurement device based on an electrocardiogram measurement value, characterized in that configured to obtain a blood glucose measurement value based on a change in the amount of current caused by the coating layer of the microneedle by supplying.

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